Feasibility and acceptability of bubble continuous positive airway pressure oxygen therapy for the treatment of childhood severe pneumonia and hypoxaemia in Bangladeshi children

Background Effective management of hypoxaemia is key to reducing pneumonia deaths in children. In an intensive care setting within a tertiary hospital in Bangladesh, bubble continuous positive airway pressure (bCPAP) oxygen therapy was beneficial in reducing deaths in this population. To inform a future trial, we investigated the feasibility of introducing bCPAP in this population in non-tertiary/district hospitals in Bangladesh. Methods We conducted a qualitative assessment using a descriptive phenomenological approach to understand the structural and functional capacity of the non-tertiary hospitals (Institute of Child and Mother Health and Kushtia General Hospital) for the clinical use of bCPAP. We conducted interviews and focus group discussions (23 nurses, seven physicians, 14 parents). We retrospectively (12 months) and prospectively (three months) measured the prevalence of severe pneumonia and hypoxaemia in children attending the two study sites. For the feasibility phase, we enrolled 20 patients with severe pneumonia (age two to 24 months) to receive bCPAP, putting in place safeguards to identify risk. Results Retrospectively, while 747 of 3012 (24.8%) children had a diagnosis of severe pneumonia, no pulse oxygen saturation information was available. Of 3008 children prospectively assessed with pulse oximetry when attending the two sites, 81 (3.7%) had severe pneumonia and hypoxaemia. The main structural challenges to implementation were the inadequate number of pulse oximeters, lack of power generator backup, high patient load with an inadequate number of hospital staff, and inadequate and non-functioning oxygen flow meters. Functional challenges were the rapid turnover of trained clinicians in the hospitals, limited post-admission routine care for in-patients by hospital clinicians due to their extreme workload (particularly after official hours). The study implemented a minimum of four hourly clinical reviews and provided oxygen concentrators (with backup oxygen cylinders), and automatic power generator backup. Twenty children with a mean age of 6.7 (standard deviation (SD) = 5.0)) months with severe pneumonia and hypoxaemia (median (md) SpO2 = 87% in room air, interquartile range (IQR) = 85-88)) with cough (100%) and severe respiratory difficulties (100%) received bCPAP oxygen therapy for a median of 16 hours (IQR = 6-16). There were no treatment failures or deaths. Conclusions Implementation of low-cost bCPAP oxygen therapy is feasible in non-tertiary/district hospitals when additional training and resources are allocated.

N.B Auto bubbling means if the bubbles are produced after initiation of oxygen but before fixing the nasal interface into the nostrils. If auto bubbling occurs, change the whole circuit and reconstruct again. 4.7 Connect the nasal prong securely to the child's nostrils.

Safety measure
The whole device or circuit is hazardous neither to patients nor to the clinical staff. Before the preparation the individual needs to wear gloves. Follow-up every 4 hourly to observe for any obstruction/disconnection/leakage, bubbling, condensate in the expiratory arm in bubble CPAP circuit, nasal trauma/bleeding, abdominal distension or rarely pneumothorax. BCPAP bottle and connecting parts can be reused by cleaning with chlorinated water properly. Each and every device will be labeled as "this device is to be used for research purposes only" which will prevent other non-specific use. The labeling, perforation and water pressure (in centimeter) marking will be done at the procurement of icddr,b. All the BCPAP bottles will be supplied from icddr,b Dhaka Hospital procurement to each District Hospital. The bottle will be kept in medical equipment containing box or almirah away from sunlight to avoid frequent handling

Quality Assurance / Quality Control
All the physicians and study nurses will be trained in this SOP. Refresher trainings will be conducted after every six months for all study staff. The site supervisor also oversees the study personnel when they assemble bubble CPAP. o How to provide the treatment? How the monitoring system has been functioning over the treatment courses? Is there found any difficulty or not? Why? How solved it? Please tell me in detail. ⎯ Is the patient or provider facing any difficulty while receiving and providing the treatment? Please probe...patient's difficulty in breathing using WHO LF, difficult to manage, staff capacity in relation to skills and knowledge gap, feeling comfort to work or not, obstacles to providing antibiotics and oxygen for children with severe pneumonia within one hour of hospitalization. Why? What were the responses of the clinical staff to the clinical problem? Explain in detail (positive and negative experiences). ⎯ What are the outcomes of current treatment practices (e.g., improved, deteriorated, refer to other hospitals, death etc.)? Explain in details the reason for each of the condition. ⎯ How much cost requires providing the current treatment? Who bear it (e.g., child's parents or hospital)? Is it feasible and cost-effective? If yes/no, why? 2. The perceived need for improved low-cost respiratory support treatment and its management capacity in the district staff ⎯ Do you feel the necessity of low cost improved respiratory support using a simple device in this district hospital for treating the severe pneumonia patients despite implementation of WHO standard LF oxygen therapy? o If yes/no, why (e.g., often death occur, expected patients volume, available human resources etc.)? o What would be the risks and benefits of its introduction within the clinical environment of the hospital? ⎯ Do you think that the existing human resources have the capacity to operate the lowcost bubble CPAP treatment using a simple device? Why you perceive this? Please explain.
o Which category staff would be included or best suited for operating the bubble CPAP in the paediatric ward? Why do you think so? o How staff capacity will boost or built if we would like to implement bubble CPAP in this hospital (based on previous experiences)? Please probe (e.g., training needs-formal training/in-service training; need more information and other support)?

Qualitative Data Collection Guidelines for Feasibility and Acceptability Assessment (after introduction of bCPAP)
For endpoint: • What are the perceptions, motivations, and attitudes towards the introduction and uses of bubble CPAP treatment in the hospital?
Guideline for conducting an in-depth interview with hospital staff (Physician/Nurse) and research staff

Background Information
• Age, sex, education, current position • Affiliated institution/ name of the hospital • Years/months of experience • Roles and responsibilities (specific role related to bubble CPAP)

Knowledge about bubble CPAP Treatment
• Do you know about the bubble CPAP treatment? Please tell me in detail. ⎯ Please probe (e.g., name, comprehensive treatment plan, benefits, and risk, the function of the machine, potential complication and solutions). How did you inform these? ⎯ What do you think about your knowledge on bubble CPAP treatment sufficient or not?
Why do you think so? Please tell me in detail.

Decisions, motivations, and attitudes towards providing the bubble CPAP treatment
• How the decision was made for providing BCPAP treatment to a patient? Tell me in detail (e.g., in which condition of child's illness). • How you motivate the patient's caregiver or guardian for providing the new treatment?
⎯ What kinds of information did you provide them? What were their responses or attitudes (e.g., positive OR negative)? ⎯ Did you face any difficulty to motivate them? If, yes/no, why? If yes, how you motivate them?
Experiences with bubble CPAP treatment practices: perceptions, motivations and attitudes • How bubble CPAP was introduced? Were you present there? What was your specific responsibilities and observation? Please probe. ⎯ Did you ever face or observe any difficulty (e.g., prepare the bubble CPAP circuit, handle nasal prong and water bottle, and operate oxygen concentration, unavailability of electricity)? If yes or no, why? What were the consequences? Explain your opinion. • Did the patient feel significant discomfort/comfort while introducing the BCPAP oxygen therapy? Why do you think so? Was there any comment from patient's guardian or caregiver (good or bad)? Please tell me detail.